A Long-term Extension Study of Apremilast (CC-10004) in Pediatric Subjects From 6 Through 17 Years of Age With Moderate to Severe Plaque Psoriasis

A Phase 3b, Multi Center, Open-label, Long-term Extension Study of Apremilast (CC-10004) in Pediatric Subjects From 6 Through 17 Years of Age With Moderate to Severe Plaque Psoriasis

This study was created to provide subjects who complete Week 52 (end of Apremilast Extension Phase) of study CC-10004-PPSO-003 the option to continue to receive open-label apremilast therapy.

The study will consist of up to 208 weeks of long-term treatment followed by an 8-week observational follow-up phase.

Study Overview

• Status: Active, not recruiting
• Conditions: Psoriasis
• Intervention / Treatment: Drug: Apremilast

• Study Type: Interventional
• Enrollment (Actual): 160
• Phase: Phase 3

Contacts and Locations

Study Locations

• Belgium
  • Brussels, Belgium, 1200
    • Cliniques Universitaires Saint Luc
  • Brussels, Belgium, 1000
    • Centre Hospitalier Universitaire Saint Pierre
  • Gent, Belgium, 9000
    • Universitair Ziekenhuis Gent
• Canada
  • Alberta
    • Edmonton, Alberta, Canada, T6G 2B7
      • Stollery Childrens Hospital
  • Manitoba
    • Winnipeg, Manitoba, Canada, R3C 0N2
      • Winnipeg Clinic Dermatology Research
  • Newfoundland and Labrador
    • St. John's, Newfoundland and Labrador, Canada, A1C 2H5
      • Karma Clinical Trials
  • Ontario
    • Toronto, Ontario, Canada, M5A 3R6
      • AvantDerm
• Czechia
  • Praha, Czechia, 120 00
    • Synexus Czech sro
  • Praha 10, Czechia, 100 34
    • Fakultni nemocnice Kralovske Vinohrady
• France
  • Martigues, France, 13500
    • Cabinet du Docteur Ruer-Mulard Mireille
  • Toulouse, France, 31000
    • Centre Hospitalier Universitaire de Toulouse - Hopital Larrey
• Israel
  • Bear Sheva, Israel, 8410101
    • Soroka University Medical Center
• Italy
  • Cagliari, Italy, 09124
    • Azienda Ospedaliero Universitaria Di Cagliari
  • Milano, Italy, 20122
    • Fondazione IRCCS Ca Granda Ospedale Maggiore Policlinico
  • Padova, Italy, 35020
    • Azienda Ospedaliera di Padova
• Russian Federation
  • Barnaul, Russian Federation, 656038
    • Altai State Medical University
  • Chelyabinsk, Russian Federation, 454048
    • Chelyabinsk Regional Clinical Skin and Venereal Dispensary
  • Ekaterinburg, Russian Federation, 620076
    • Ural Scientific Research Institute of Dermatovenereology and Immunopathology
  • Kazan, Russian Federation, 420012
    • Republican Clinical Dermatology and Venerology Dispensary
  • Krasnodar, Russian Federation, 350020
    • Clinical Dispensary of Dermatology and Venereology of Krasnodar Territory of the Ministry of Health
  • Moscow, Russian Federation, 107076
    • State Scientific Center for Dermatovenereology and Cosmetology
  • Moscow, Russian Federation, 119071
    • Moscow Scientific Practical Center of Dermatology Venerology and Cosmetology
  • Moscow, Russian Federation, 119991
    • National Medical Research Center for Children Health
  • Novosibirsk, Russian Federation, 630099
    • LLC Medical Center Zdorovaya Semiya
  • Saint Petersburg, Russian Federation, 194100
    • Saint Petersburg State Pediatric Medical University
  • Saint Petersburg, Russian Federation, 191123
    • Pierre Wolkenshtein Skin Diseases Clinic LLC
  • Saint Petersburg, Russian Federation, 196158
    • LLC PiterKlinika
  • Ufa, Russian Federation, 450083
    • Bashkiria State Medical University
  • Yaroslavl, Russian Federation, 150000
    • Yarosavl State Medical Academy
• Spain
  • Alicante, Spain, 3010
    • General University Hospital of Alicante
  • Badalona, Spain, 08916
    • Hopsital Germans Trias I Pujol
  • Madrid, Spain, 28009
    • Hospital Infantil Universitario Nino Jesus
  • Madrid, Spain, 28046
    • Hospital La Paz
  • Madrid, Spain, 28007
    • Hospital General Universitario Gregorio Maranon
  • Madrid, Spain, 28041
    • Hospital 12 de Octubre
  • Santander, Spain, 39008
    • Hospital Marques de Valdecilla
  • Cataluña
    • Esplugues de Llobregat, Cataluña, Spain, 08950
      • Hospital Sant Joan De Deu
• United States
  • Arizona
    • Phoenix, Arizona, United States, 85016
      • Phoenix Childrens Hospital
  • Arkansas
    • Fort Smith, Arkansas, United States, 72916
      • Johnson Dermatology Clinic
  • California
    • Irvine, California, United States, 92697
      • First OC Dermatology
    • Palo Alto, California, United States, 94304
      • Stanford University School of Medicine
    • Thousand Oaks, California, United States, 91320
      • California Dermatology Institute
  • Florida
    • Jacksonville, Florida, United States, 32256
      • Solutions Through Advanced Research Inc
    • Miami, Florida, United States, 33173
      • Ciocca Dermatology
  • Georgia
    • Macon, Georgia, United States, 31217
      • Skin Care Physicians of Georgia
  • Indiana
    • Indianapolis, Indiana, United States, 46256
      • Dawes Fretzin Dermatology Group Inc
  • Ohio
    • Fairborn, Ohio, United States, 45324
      • Wright State Physicians
  • South Carolina
    • Charleston, South Carolina, United States, 29425
      • Medical University of South Carolina
  • Texas
    • San Antonio, Texas, United States, 78218
      • Driscoll Children's Hospital
  • Wisconsin
    • Madison, Wisconsin, United States, 53715-1375
      • University of Wisconsin Hospital and Clinics

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 6 years to 17 years (Child)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

Subject must satisfy the following criteria to be enrolled in the study:

1. Subject is male or female 6 to 17 years of age, inclusive, at the time the informed consent document is signed by the legal guardian.
2. Subject must have a weight of ≥ 20 kg.
3. Subjects must have an age and sex specific BMI value no lower in range than the 5th percentile on the Centers for Disease Control (CDC) growth chart for children and adolescents.
4. Subject must have completed Week 52 (Apremilast Extension Phase) of Study CC-10004-PPSO-003.
5. Subject is able to sign an assent with a legal guardian/s who understand/s and voluntarily sign/s an informed consent prior to any study-related assessments/procedures being conducted.
6. Subject is willing and able to adhere to the study visit schedule and other protocol requirements.
7. All female subjects of childbearing potential (FCBP) must either practice abstinence from heterosexual contact or use one of the approved contraceptive options as described below while on apremilast and for at least 28 days after administration of the last dose of apremilast. For the purpose of this study, a female subject is considered of childbearing potential if she is ≥ 12 years old or has reached menarche, whichever occurred first.

At the time of study entry, and at any time during the study when a female subject of childbearing potential's contraceptive measures or ability to become pregnant changes, the Investigator will educate the subject regarding abstinence or contraception options and the correct and consistent use of effective contraceptive methods in order to successfully prevent pregnancy.

Females of childbearing potential must have a negative pregnancy test at each visit. All FCBP who engage in activity in which conception is possible must use one of the approved contraceptive options described below:

Option 1: Any one of the following effective methods: hormonal contraception (oral, injection, implant, transdermal patch, vaginal ring); intrauterine device (IUD); tubal ligation; or partner's vasectomy;

OR

Option 2: Male or female condom or nonlatex condom NOT made out of natural [animal] membrane [for example, polyurethane]; PLUS one additional barrier method:

(a) diaphragm with spermicide; (b) cervical cap with spermicide; or (c) contraceptive sponge with spermicide.

NOTE: Option 2 may not be acceptable as a contraception option in all countries per local guidelines/regulations.

Exclusion Criteria:

The presence of any of the following will exclude a subject from enrollment:

1. Subject has a condition, including the presence of laboratory abnormalities, or psychiatric illness, that would place the subject at unacceptable risk if he/she were to participate in the study.
2. Subject has a condition that confounds the ability to interpret data from the study.
3. Subject has evidence of skin conditions, other than psoriasis, that would interfere with clinical assessments.
4. Subject is pregnant or breastfeeding.
5. Subject has guttate, erythrodermic, or pustular psoriasis.
6. Subject has active tuberculosis (TB) or a history of incompletely treated TB.
7. Subject answers "Yes" to any question on the Columbia-Suicide Severity Rating Scale at Visit 16 of study CC-10004-PPSO-003.

8. Subject plans concurrent use of the following therapies that may have a possible effect on psoriasis.

   1. Conventional systemic therapy for psoriasis (including but not limited to cyclosporine, corticosteroids, methotrexate, oral retinoids, mycophenolate, thioguanine, hydroxyurea, sirolimus, sulfasalazine, azathioprine, and fumaric acid esters)
   2. Biologic therapy:

   i. Etanercept (or biosimilar) treatment ii. Adalimumab (or biosimilar) treatment iii. Other TNF or interleukin (IL)-17 blockers (such as infliximab, certolizumab pegol, secukinumab, ixekizumab, brodalumab, or their biosimilars) iv. Anti-IL-12 or anti-IL-23 treatment (such as ustekinumab, guselkumab, or tildrakizumab) c) Use of any investigational drug other than apremilast

9. Subject has prolonged sun exposure or use of tanning booths or other ultraviolet (UV) light sources.
10. Children in Care: a child who has been placed under the control or protection of an agency, organization, institution or entity by the courts, the government or a government body, acting in accordance with powers conferred on them by law or regulation.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Patients treated with Apremilast; Subjects with a weight between 20 kg to < 50 kg will receive apremilast 20 mg BID and subjects with weight ≥ 50 kg at Visit 1 will receive apremilast 30 mg BID. Subjects that begin the study receiving apremilast 20 mg BID and later record a body weight ≥ 50 kg, will be switched to apremilast 30 mg BID.	Drug: Apremilast; Apremilast dose will be increased from 20 mg BID to 30 mg BID for those subjects that reach a weight of 50 kg or more during the study; Other Names: CC-10004, Otezla

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Adverse Events (AEs)	An AE is any noxious, unintended, or untoward medical occurrence that may appear or worsen in a subject during the course of a study. It may be a new intercurrent illness, a worsening concomitant illness, an injury, or any concomitant impairment of the subject's health, including laboratory test values, regardless of etiology. Any worsening (ie, any clinically significant adverse change in the frequency or intensity of a preexisting condition) should be considered an AE.	Up to approximately 4 years
Columbia-Suicide Severity Rating Scale (C-SSRS)	Questionnaire to monitor depression, suicidal thoughts and behavior	Collected at each study visit throughout the life of the study - up to 4 years
Weight of patients treated with Apremilast	Body weight in kg	Collected at each study visit throughout the life of the study - up to 4 years
Mean body mass index of the patient treated with Apremilast	BMI (combined outcome of weight and height in the form of kg/m^2)	Collected at each study visit throughout the life of the study - up to 4 years
Height patients treated with Apremilast	Height (inches or centimeters) will be collected for all pediatric subjects and descriptively summarized	Collected at each study visit throughout the life of the study - up to 4 years
Assessment of sexual maturity	Sexual maturation, assessed by Tanner staging system, will be conducted for all pediatric subjects and descriptively summarized	Collected every 52 weeks throughout the life of the study - up to 4 years

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Static Physician Global Assessment (sPGA)	is the assessment by the Investigator of the overall disease severity at the time of evaluation. The sPGA is a 5-point scale ranging from 0 (clear) to 4 (severe), incorporating an assessment of the severity of the three primary signs of the disease: erythema, scaling and plaque elevation.	Collected at each study visit throughout the life of the study - up to 4 years

Collaborators and Investigators

• Sponsor: Amgen
• Investigators: Study Director: MD, Amgen

Publications and helpful links

Helpful Links

• AmgenTrials clinical trials website

Study record dates

Study Major Dates

• Study Start (Actual): December 20, 2019
• Primary Completion (Actual): March 27, 2023
• Study Completion (Estimated): February 22, 2027

Study Registration Dates

• First Submitted: November 21, 2019
• First Submitted That Met QC Criteria: November 21, 2019
• First Posted (Actual): November 25, 2019

Study Record Updates

• Last Update Posted (Actual): February 8, 2024
• Last Update Submitted That Met QC Criteria: February 7, 2024
• Last Verified: February 1, 2024

More Information

Terms related to this study

• Keywords: Pediatric; Plaque Psoriasis; CC-10004; Apremilast; Age 6 - 17 years
• Additional Relevant MeSH Terms: Skin Diseases; Skin Diseases, Papulosquamous; Psoriasis; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Peripheral Nervous System Agents; Enzyme Inhibitors; Analgesics; Sensory System Agents; Anti-Inflammatory Agents, Non-Steroidal; Analgesics, Non-Narcotic; Anti-Inflammatory Agents; Antirheumatic Agents; Phosphodiesterase Inhibitors; Phosphodiesterase 4 Inhibitors; Apremilast
• Other Study ID Numbers: CC-10004-PPSO-004; U1111-1242-3537 (Other Identifier: WHO); 2019-003497-13 (EudraCT Number)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: De-identified individual patient data for variables necessary to address the specific research question in an approved data sharing request
• IPD Sharing Time Frame: Data sharing requests relating to this study will be considered beginning 18 months after the study has ended and either 1) the product and indication (or other new use) have been granted marketing authorization in both the US and Europe or 2) clinical development for the product and/or indication discontinues and the data will not be submitted to regulatory authorities. There is no end date for eligibility to submit a data sharing request for this study.
• IPD Sharing Access Criteria: Qualified researchers may submit a request containing the research objectives, the Amgen product(s) and Amgen study/studies in scope, endpoints/outcomes of interest statistical analysis plan, data requirements, publication plan, and qualifications of the researcher(s). In general, Amgen does not grant external requests for individual patient data for the purpose of re-evaluating safety and efficacy issues already addressed in the product labelling. Requests are reviewed by a committee of internal advisors, and if not approved, may be further arbitrated by a Data Sharing Independent Review Panel. Upon approval, information necessary to address the research question will be provided under the terms of a data sharing agreement. This may include anonymized individual patient data and/or available supporting documents, containing fragments of analysis code where provided in analysis specifications. Further details are available at the URL below.
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP; ICF; CSR

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No